|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 October 2017 |
|
Main ID: |
NCT01263561 |
|
Date of registration:
|
14/12/2010 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy
|
|
Scientific title:
|
Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy |
|
Date of first enrolment:
|
April 2009 |
|
Target sample size:
|
64 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01263561 |
|
Study type:
|
Interventional |
|
Study design:
|
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Canada
| | | | | | | |
|
Contacts
|
|
Name:
|
Yvonne M Buys, Professor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Toronto |
|
|
Name:
|
Graham E Trope, Professor |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Toronto |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- age 18 to 85
- open-angle glaucoma uncontrolled medically
- intraocular pressure = 18 mmHg
- trabeculectomy as the planned surgical procedure
Exclusion Criteria:
- any previous ocular incisional surgery with the exception of previous clear
- cornea cataract surgery
- uveitis
- vitreous present in anterior chamber
- patient unwilling or unable to accept randomization or to give consent or to attend
the follow up visits
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Glaucoma
|
|
Intervention(s)
|
|
Procedure: ExPRESS shunt
|
|
Procedure: trabeculectomy
|
|
Primary Outcome(s)
|
|
Success Rate (IOP Between 5-18 mmHg and 20% Reduction From Baseline) Without Glaucoma Medication
[Time Frame: 1 year post surgery]
|
|
Intraocular Pressure
[Time Frame: 1 year post surgery]
|
|
Secondary Outcome(s)
|
|
Complications
[Time Frame: 1 year post surgery]
|
|
Secondary ID(s)
|
|
07-0888-A
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|